Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: First report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial
dc.contributor.author | Fountzilas, George | en |
dc.contributor.author | Dafni, U. | en |
dc.contributor.author | Papadimitriou, C. | en |
dc.contributor.author | Timotheadou, E. | en |
dc.contributor.author | Gogas, H. | en |
dc.contributor.author | Eleftheraki, A. G. | en |
dc.contributor.author | Xanthakis, I. | en |
dc.contributor.author | Christodoulou, C. | en |
dc.contributor.author | Koutras, A. K. | en |
dc.contributor.author | Papandreou, C. N. | en |
dc.contributor.author | Papakostas, P. | en |
dc.contributor.author | Miliaras, S. | en |
dc.contributor.author | Markopoulos, C. | en |
dc.contributor.author | Dimitrakakis, C. | en |
dc.contributor.author | Korantzopoulos, Panagiotis | en |
dc.contributor.author | Karanikiotis, C. | en |
dc.contributor.author | Bafaloukos, Dimitrios | en |
dc.contributor.author | Kosmidis, Paraskevas A. | en |
dc.contributor.author | Samantas, E. | en |
dc.contributor.author | Varthalitis, I. | en |
dc.contributor.author | Pavlidis, Nicholas | en |
dc.contributor.author | Pectasides, Dimitrios | en |
dc.contributor.author | Dimopoulos, M. A. | en |
dc.creator | Fountzilas, George | en |
dc.creator | Dafni, U. | en |
dc.creator | Papadimitriou, C. | en |
dc.creator | Timotheadou, E. | en |
dc.creator | Gogas, H. | en |
dc.creator | Eleftheraki, A. G. | en |
dc.creator | Xanthakis, I. | en |
dc.creator | Christodoulou, C. | en |
dc.creator | Koutras, A. K. | en |
dc.creator | Papandreou, C. N. | en |
dc.creator | Papakostas, P. | en |
dc.creator | Miliaras, S. | en |
dc.creator | Markopoulos, C. | en |
dc.creator | Dimitrakakis, C. | en |
dc.creator | Korantzopoulos, Panagiotis | en |
dc.creator | Karanikiotis, C. | en |
dc.creator | Bafaloukos, Dimitrios | en |
dc.creator | Kosmidis, Paraskevas A. | en |
dc.creator | Samantas, E. | en |
dc.creator | Varthalitis, I. | en |
dc.creator | Pavlidis, Nicholas | en |
dc.creator | Pectasides, Dimitrios | en |
dc.creator | Dimopoulos, M. A. | en |
dc.date.accessioned | 2018-06-22T09:53:04Z | |
dc.date.available | 2018-06-22T09:53:04Z | |
dc.date.issued | 2014 | |
dc.identifier.uri | https://gnosis.library.ucy.ac.cy/handle/7/41647 | |
dc.description.abstract | Background: Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet.Methods: From July 2005 to November 2008, 1001 patients (990 eligible) were randomized to receive, every 2 weeks, 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of intensified CMF (Arm A; 333 patients), or 3 cycles of epirubicin followed by 3 cycles of CMF, as in Arm A, followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 (Arm B; 331), or 9 weekly cycles of paclitaxel 80 mg/m2 (Arm C; 326). Trastuzumab was administered for one year to HER2-positive patients post-radiation.Results: At a median follow-up of 60.5 months, the 3-year disease-free survival (DFS) rate was 86%, 90% and 88%, for Arms A, B and C, respectively, while the 3-year overall survival (OS) rate was 96% in all arms. No differences were found in DFS or OS between the combined B and C Arms versus Arm A (DFS: HR = 0.81, 95% CI: 0.59-1.11, P = 0.20; OS: HR = 0.84, 95% CI: 0.55-1.30, P = 0.43). Among the 255 patients who received trastuzumab, 189 patients (74%) completed 1 year of treatment uneventfully. In all arms, the most frequently reported severe adverse events were neutropenia (30% vs. 27% vs. 26%) and leucopenia (12% vs. 13% vs. 12%), while febrile neutropenia occurred in fifty-one patients (6% vs. 4% vs. 5%). Patients in Arm A experienced more often severe pain (P = 0.002), neurological complications (P = 0.004) and allergic reactions (P = 0.004), while patients in Arm B suffered more often from severe skin reactions (P = 0.020).Conclusions: No significant differences in survival between the regimens were found in the present phase III trial. Taxane scheduling influenced the type of severe toxicities. HER2-positive patients demonstrated comparable 3-year DFS and OS rates with those reported in other similar studies.Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12610000151033. © 2014 Fountzilas et al.; licensee BioMed Central Ltd. | en |
dc.language.iso | eng | en |
dc.source | BMC Cancer | en |
dc.subject | Article | en |
dc.subject | Antineoplastic agent | en |
dc.subject | Antineoplastic agents | en |
dc.subject | Cyclophosphamide | en |
dc.subject | Fluorouracil | en |
dc.subject | Human | en |
dc.subject | Methotrexate | en |
dc.subject | Tamoxifen | en |
dc.subject | Humans | en |
dc.subject | Adult | en |
dc.subject | Aged | en |
dc.subject | Breast neoplasms | en |
dc.subject | Controlled study | en |
dc.subject | Female | en |
dc.subject | Major clinical study | en |
dc.subject | Cancer combination chemotherapy | en |
dc.subject | Chemotherapy | en |
dc.subject | Follow up | en |
dc.subject | Paclitaxel | en |
dc.subject | Anorexia | en |
dc.subject | Antineoplastic combined chemotherapy protocols | en |
dc.subject | Arthralgia | en |
dc.subject | Clinical trial | en |
dc.subject | Diarrhea | en |
dc.subject | Disease-free survival | en |
dc.subject | Drug efficacy | en |
dc.subject | Fatigue | en |
dc.subject | Febrile neutropenia | en |
dc.subject | Infection | en |
dc.subject | Leukopenia | en |
dc.subject | Mucosa inflammation | en |
dc.subject | Multicenter study | en |
dc.subject | Myalgia | en |
dc.subject | Neutropenia | en |
dc.subject | Skin disease | en |
dc.subject | Disease free survival | en |
dc.subject | Drug administration | en |
dc.subject | Drug administration schedule | en |
dc.subject | Drug fatality | en |
dc.subject | Granulocyte colony stimulating factor | en |
dc.subject | Pain | en |
dc.subject | Patient compliance | en |
dc.subject | Phase 3 clinical trial | en |
dc.subject | Randomized controlled trial | en |
dc.subject | Survival rate | en |
dc.subject | Docetaxel | en |
dc.subject | Overall survival | en |
dc.subject | Cancer radiotherapy | en |
dc.subject | Epirubicin | en |
dc.subject | Adjuvant | en |
dc.subject | Antibodies | en |
dc.subject | Neurologic disease | en |
dc.subject | Side effect | en |
dc.subject | Vomiting | en |
dc.subject | Follow-up studies | en |
dc.subject | Monoclonal antibody | en |
dc.subject | Breast cancer | en |
dc.subject | Mastectomy | en |
dc.subject | Cancer adjuvant therapy | en |
dc.subject | Nausea | en |
dc.subject | Pathology | en |
dc.subject | Multiple cycle treatment | en |
dc.subject | Drug withdrawal | en |
dc.subject | Gastrointestinal disease | en |
dc.subject | Middle aged | en |
dc.subject | Young adult | en |
dc.subject | Heart disease | en |
dc.subject | Eye disease | en |
dc.subject | Aromatase inhibitor | en |
dc.subject | Comparative study | en |
dc.subject | Metabolic disorder | en |
dc.subject | Vascular disease | en |
dc.subject | Edema | en |
dc.subject | Neutrophil | en |
dc.subject | Monoclonal | en |
dc.subject | Trastuzumab | en |
dc.subject | Anastrozole | en |
dc.subject | Anthracyclines | en |
dc.subject | Epidermal growth factor receptor 2 | en |
dc.subject | Phase 3 clinical trial (topic) | en |
dc.subject | Taxanes | en |
dc.subject | Adjuvant chemotherapy | en |
dc.subject | Allergic reaction | en |
dc.subject | Asymptomatic disease | en |
dc.subject | Dose-dense sequential chemotherapy | en |
dc.subject | Early cancer | en |
dc.subject | Fulvestrant | en |
dc.subject | Gonadorelin | en |
dc.subject | Goserelin | en |
dc.subject | Heart ejection fraction | en |
dc.subject | Heart failure | en |
dc.subject | Hemoglobin | en |
dc.subject | Humanized | en |
dc.subject | Leukocyte | en |
dc.subject | Loading drug dose | en |
dc.subject | Lung disease | en |
dc.subject | Lymphocytopenia | en |
dc.subject | Open study | en |
dc.subject | Partial mastectomy | en |
dc.subject | Skin manifestation | en |
dc.subject | Thrombocyte | en |
dc.title | Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: First report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial | en |
dc.type | info:eu-repo/semantics/article | |
dc.identifier.doi | 10.1186/1471-2407-14-515 | |
dc.description.volume | 14 | |
dc.description.issue | 1 | |
dc.author.faculty | Ιατρική Σχολή / Medical School | |
dc.author.department | Ιατρική Σχολή / Medical School | |
dc.type.uhtype | Article | en |
dc.contributor.orcid | Pavlidis, Nicholas [0000-0002-2195-9961] | |
dc.gnosis.orcid | 0000-0002-2195-9961 |
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